Status:
COMPLETED
Safety and Efficacy Study of Isolagen TherapyTM in Treatment of Facial Wrinkles and Creases
Lead Sponsor:
Castle Creek Biosciences, LLC.
Conditions:
Facial Wrinkles and Creases
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
The purpose of this study is to evaluate the safety profile and the treatment effect of autologous human fibroblasts and placebo when administered to facial wrinkles and creases
Eligibility Criteria
Inclusion
- Male or female, at least 18 years of age
- High Investigator wrinkle severity assessment score
- Subject assessment of dissatisfaction of facial appearance
- Provide written informed consent and comply with the study requirements
- Negative pregnancy test at screening visit
- Healthy, non-scarred skin for biopsy
Exclusion
- Low Investigator wrinkle severity assessment score
- Subject assessment of satisfaction of facial appearance
- Physical attributes which prevent the assessment or treatment of the facial wrinkles
- Treatment with an investigational product or procedure within 30 days or plans to participate in another clinical trial
- Previous treatment with Isolagen Therapy
- History of active autoimmune disease or organ transplantation
- Diagnosis of cancer, receiving active treatment
- History of pigmentary disorders which can affect the face
- Active or chronic skin disease
- Known genetic disorders affecting fibroblasts or collagen
- Active systemic infection
- Requires chronic antibiotic or steroidal therapy
- Use of certain cosmetic treatments \& procedures
- Use of systemic agents that increase bleeding or clotting, or disorders equated with these effects
- Pregnant or lactating women or women trying to become pregnant
- Known allergic reaction to components of study treatment and/or study injection procedure
- Excessive exposure to sun or sunburn in the post-auricular area
- Subject has any disorder that may prevent compliance
- Subject who is part of the study staff, a family member or friend
Key Trial Info
Start Date :
March 1 2007
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2008
Estimated Enrollment :
50 Patients enrolled
Trial Details
Trial ID
NCT00654654
Start Date
March 1 2007
End Date
June 1 2008
Last Update
March 13 2012
Active Locations (5)
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1
Rhonda Rand, M.D., Inc.
Beverly Hills, California, United States, 90210
2
The Laser Institute for Dermatology
Santa Monica, California, United States, 90404
3
Winter Park and Orlando Plastic Surgery
Orlando, Florida, United States, 32804
4
Dermatology Partners
Wellesley, Massachusetts, United States, 02481